Diabetes is a serious disease that can develop from lack of insulin production in the body or due to the inability of the body's insulin to perform its normal everyday functions. Insulin is a substance produced by the pancreas gland that helps process ingested food and turn it into energy.
Diabetes affects approximately 25.8 million Americans as per a 2011 NIH study. An estimated 285 million people, corresponding to 6.4% of the world's adult population, will live with diabetes in 2010. The number is expected to grow to 438 million by 2030, corresponding to 7.8% of the adult population according a recent WHO study. Diabetes is classified into 2 different types: Type 1 and Type 2. Type 1 is usually associated with juvenile diabetes and is often linked to heredity. Type 2, commonly referred to as adult onset diabetes, is characterized by elevated blood sugars, often in people who are overweight or have not attended to their diet properly.
Many complications can be associated with diabetes. Diabetes disrupts the vascular system, affecting many areas of the body such as the eyes, kidneys, legs, and feet. People with diabetes should pay special attention to their feet, as 25% of diabetic patients will develop foot problems related to the disease.
Diabetic foot conditions develop from a combination of causes including poor circulation and neuropathy. Diabetic neuropathy can cause insensitivity or a loss of ability to feel pain, heat, and cold. Diabetics suffering from neuropathy can develop minor cuts, scrapes, blisters, or pressure sores that they may not be aware of due to the insensitivity. If these minor injuries are left untreated, complications may result and lead to ulceration and possibly even amputation. Neuropathy can also cause deformities such as bunions, hammer toes, and Charcot feet.
Peripheral neuropathy can be brought about by diseases or conditions other than diabetes. Examples of such diseases or conditions include trauma (e.g., motor vehicle accidents, falls or sports injuries), prolonged pressure (e.g., using a cast or crutches), repetitive motions (e.g., typing), vitamin deficiencies (e.g., lacking in vitamins B-1, B-6, B-12, E and niacin), alcoholism, infections (e.g., certain viral or bacterial infections including Lyme disease, shingles (varicella-zoster), Epstein-Barr, hepatitis C and HIV/AIDS), autoimmune diseases (e.g., lupus, rheumatoid arthritis and Guillain-Barre syndrome), kidney disease, liver disease, underactive thyroid (hypothyroidism), inherited disorders (e.g., Charcot-Marie-Tooth disease and amyloid polyneuropathy), tumors, and exposure to poisons (e.g., toxic substances like heavy metals and certain medications like those used to treat cancer (chemotherapy)).
Diabetes often leads to peripheral vascular disease that inhibits a person's blood circulation. With this condition, there is a narrowing of the arteries that frequently leads to significantly decreased circulation in the lower part of the legs and the feet. Poor circulation contributes to diabetic foot problems by reducing the amount of oxygen and nutrition supplied to the skin and other tissue, causing injuries to heal poorly. Poor circulation can also lead to swelling and dryness of the foot. Preventing foot complications is more critical for the diabetic patient because poor circulation impairs the healing process and can lead to ulcers, infection, and other serious foot conditions.
Peripheral vascular disease can be brought about by diseases or conditions other than diabetes. Examples of such diseases or conditions include vasculitis (inflammation of the blood vessels, occurring either as a primary condition or associated with connective tissue diseases such as lupus), injuries to blood vessels (from accidents such as auto accidents or sports injuries), blood-clotting disorders, and damage to blood vessels during surgery.
The aforementioned vascular and neurological issues can lead to erectile dysfunction (ED) in males. ED can be defined as persistent failure to generate sufficient penile body pressure to achieve vaginal penetration and/or the inability to maintain this degree of penile rigidity until ejaculation. Erectile dysfunction is common among men of all ages, ethnicities, and cultural backgrounds. It has been recently estimated that more than 152 million men worldwide experienced ED in 1995, and that this number will rise by 170 million, to approximately 322 million by the year 2025. Although the exact prevalence of erectile dysfunction in the United States male population is not known, estimates have ranged from 12% of males above age 18 to 25-30% of men between ages 60 and 70.
There is a need in the art for systems, devices, and methods for preventing, managing and/or treating diabetic neuropathy and peripheral vascular disease and related conditions, such as, for example, ED.